Comparison of Two Different Pain Management Techniques in Pediatric Patients Undergoing a Hernia Repair

Unilateral inguinal herniorrhaphy is a commonly performed surgical procedure in the pediatric
population. Multimodal anesthesia consisting of systemic narcotics, surgical wound
infiltration with local anesthetic and ilioinguinal and/or iliohypogastric nerve blockade has
traditionally been employed to achieve acceptable analgesia. Recently, ultrasound-based
studies have demonstrated that blind abdominal wall injections are done with poor accuracy.
Ultrasound-guided alternatives, such as the transverses abdominis plane (TAP) block, may
improve analgesic efficacy and patient comfort in the post-operative period when compared to
blind landmark based nerve blockade. There has been increasing utilization of the TAP block
in the adult population due to the described ability to provide effective blockade of the
thoracolumbar spinal nerves innervating the abdominal wall. We propose a randomized
prospective evaluation of the analgesic efficacy comparing surgeon performed
ilioinguinal/iliohypogastric block with ultrasound-guided TAP blockade in healthy ASA I and
II pediatric patients undergoing unilateral herniorrhaphy on an outpatient basis.

Inclusion Criteria:

- The subject is male or female;

- The subject is of any racial and ethnic groups;

- The subject is age 12 months to 10 years (inclusive);

- The subject weighs more than 8.0 kg (inclusive of the eighth kilogram);

- The subject is scheduled for the following: Unilateral herniorrhaphy scheduled on an
out-patient basis, and not being performed in conjunction with any other surgical
procedures;

- The subject is American Society of Anesthesiologists (ASA) patient classification I-II

- The subject's legally authorized representative has given written informed consent to
participate in the study and when appropriate, the subject has given assent or consent
to participate.

Exclusion Criteria:

- Additional surgical procedures are being performed concurrently;

- The subject is ASA classification > II;

- The subject has pre-existing allergies to local anesthetics;

- The subject receives midazolam as a premedication;

- The subject has an imminent life threatening condition that impacts the ability to
obtain informed consent;

- The subject has any other condition, which in the opinion of the principal
investigator, would not be suitable for participation in the study.